Azithromycin Dihydrate
- Product NDC
- 70518-4105
- 11-digit product format
- 705184105
- Labeler code
- 70518
- Product ID
- 70518-4105_49ff5d61-b7a0-9f10-e063-6394a90a25fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA208249
- Marketing category
- ANDA
- Marketing start
- 2024-06-17
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azithromycin Dihydrate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN DIHYDRATE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5FD1131I7S |
| Rxcui | 248656 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4105-0 | Azithromycin Dihydrate | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 3 |
| 70518-4105-1 | Azithromycin Dihydrate | 5 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4105 | AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [REMEDYREPACK INC.] | 1 | Current NDC, 2 package rows | 20240618_7711e846-0bb3-486c-8511-f445e264cd98.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4105-0 | 70518410500 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4105-0) | 2024-06-17 | No | No | Historical |
| 70518-4105-1 | 70518410501 | 5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4105-1) | 2026-02-03 | No | No | Historical |